Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 5 for:    COVID-19 Infection Using Wharton's Jelly

Treatment of Respiratory Complications Associated With COVID-19 Infection Using ProTrans®

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04896853
Recruitment Status : Recruiting
First Posted : May 21, 2021
Last Update Posted : May 21, 2021
Sponsor:
Collaborator:
Karolinska Trial Alliance
Information provided by (Responsible Party):
NextCell Pharma Ab

Brief Summary:
The investigators hypothesise that the systemic delivery of Wharton's Jelly (WJ)-Umbilical Cord (UC) Mesenchymal Stromal Cells (MSC), WJ-MSCs exerts an anti-inflammatory action and anti-apoptotic effect in the lung of COVID-19 patients. The nature of these cells to immunomodulate both tissue resident and bloodborne immune cells towards a more anti-inflammatory and tolerogenic profile, results in a reduction of tissue-based inflammation within the lung and triggering of repair responses. This clinically culminates in a beneficial action on patients with respiratory complications associated with coronavirus disease 2019 (COVID-19) infection.

Condition or disease Intervention/treatment Phase
COVID-19 Acute Respiratory Distress Syndrome Biological: ProTrans® Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is an open, dose escalating Phase IB Clinical Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Respiratory Complications Associated With COVID-19 Infection Using Wharton's Jelly (WJ)-Umbilical Cord (UC) Mesenchymal Stromal Cells (ProTrans®): Open Phase IB Clinical Trial
Actual Study Start Date : May 18, 2021
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : December 31, 2024


Arm Intervention/treatment
Experimental: Treatment
Wharton's Jelly (WJ)-Umbilical Cord (UC) Mesenchymal Stromal Cells (ProTrans®).Study patients 1-3 will receive a single dose of 25 million cells, patients 4-6 will receive 100 million cells and patients 7-9 will receive 200 million cells.
Biological: ProTrans®
Allogeneic Wharton's jelly (WJ) Mesenchymal Stromal Cells




Primary Outcome Measures :
  1. Safety and tolerance of a single infusion of ProTrans® [ Time Frame: 24 months ]
    Grade 3 or 4 adverse event but not usual in natural course of the disease.

  2. Effect of ProTrans® -MSC on patient clinical status, including mortality [ Time Frame: 15 days ]
    The rate of use of mechanical ventilation (necessitating intubation) or death.


Secondary Outcome Measures :
  1. Effect of ProTrans® -MSC on patient clinical status, including mortality, at day 7 [ Time Frame: 7 days ]
    Effect of ProTrans® -MSC on patient clinical status assessed on the 7-point ordinal scale; 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO) 7. Death.

  2. Effect of ProTrans® -MSC on patient clinical status, including mortality, at day 15 [ Time Frame: 15 days ]
    Effect of ProTrans® -MSC on patient clinical status assessed on the 7-point ordinal scale; 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or ECMO 7. Death.

  3. Effect of ProTrans® -MSC on patient clinical status, including mortality, at day 30 [ Time Frame: 30 days ]
    Effect of ProTrans® -MSC on patient clinical status assessed on the 7-point ordinal scale; 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or ECMO 7. Death.

  4. Time to clinical improvement after ProTrans® - MSC infusion [ Time Frame: 30 days ]
    Time to clinical improvement of one category from admission on the 7-point ordinal scale after ProTrans® - MSC infusion

  5. Effect of of ProTrans® -MSC on lung damage [ Time Frame: Up to 60 days ]
    Size of Chest lesion on lung damage using imaging techniques (Chest X ray/CT scan /or on doppler ultrasound) when assessed for clinical need up to hospital discharge X ray/CT scan /or on doppler ultrasound) when assessed for clinical need

  6. Duration of hospitalization and Intensive Care Unit (ICU) stay [ Time Frame: Up to 60 days ]
    Duration of hospitalization and ICU stay

  7. Kinetics of COVID-19 viral load after ProTrans® -MSC infusion [ Time Frame: 30 days ]
    Quantitative PCR for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus in throat swabs (time frame: before MSC infusion on Day 0 and after MSC infusion on day 30



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female, aged 18 - 75 years old
  • Has laboratory-confirmed SARS-CoV-2 infection as determined by reverse-transcription polymerase chain reaction (RT-PCR) in any specimen prior to inclusion.
  • Hospitalized patients not previously admitted due to COVID-19 infection
  • Patients classified as severe pneumonia, as defined by the need for continuous supplemental oxygen 5 L/min 02 OR high flow oxygen, 50% Fraction of Inspired Oxyge (FiO2) ≥ 30 l/min and cannot saturate > 96% not under "non-invasive" ventilation nor invasive mechanical ventilation nor ECMO
  • Women of childbearing potential must agree to use contraception or acceptable birth control for the duration of the study.

Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation 1:

  • oral
  • intravaginal
  • transdermal, progestogen-only hormonal contraception associated with inhibition of ovulation 1:
  • oral
  • injectable
  • implantable 2; intrauterine device (IUD) 2, intrauterine hormone-releasing system (IUS) 2, bilateral tubal occlusion 2, vasectomised partner 2,3, sexual abstinence 4

    1. Hormonal contraception may be susceptible to interaction with the Investigational Medicinal Products (IMP), which may reduce the efficacy of the contraception method
    2. Contraception methods that in the context of this guidance are considered to have low user dependency.
    3. Vasectomised partner is a highly effective birth control method provided that partner is the sole sexual partner of the trial participant and that the vasectomised partner has received medical assessment of the surgical success. 4 In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.

      • Provision of a written informed consent

Exclusion Criteria:

  • Inability to provide informed consent
  • Patients not expected to survive for 24 hours or mechanically ventilated at inclusion or previously during present hospitalization
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotrophin (hCG) laboratory test
  • Patients with weight > 100 kg or weight < 50 kg
  • Patients with known, or previous, malignancy
  • Patients with other serious systemic diseases deemed of contra-indication by the physician
  • Patient with any of following laboratory results out of the ranges detailed below at screening: Absolute neutrophil count (ANC) ≤ 1.0 x 10e9/L, Platelets (PLT) < 50 10e9 /L, ASAT or ALAT > 5N, estimated glomerular filtration rate (eGFR) < 30 mL/min
  • Current documented bacterial infection
  • Serological evidence of infection with human immunodeficiency virus, Treponema pallidum, hepatitis B antigen (serology consistent with previous vaccination and a history of vaccination is acceptable) or hepatitis C
  • Latent or previous as well as on-going therapy against tuberculosis, or exposed to tuberculosis or have travelled in areas with high risk of tuberculosis or mycosis within the last 3 months
  • Patients with known allergies to a component of the ProTrans® product
  • Ongoing treatment with Remdesivir
  • Pre-existing chronic respiratory diseases requiring long- term oxygen therapy
  • Pre-existing cirrhosis with basal Child and Pugh of C
  • Patients with history of increased risk for thrombo- embolic and/or co-morbidity for thrombo- embolism
  • Patients with a history of myocardium infarction
  • A history of cardiac dysfunction, as assessed as:

Clinical sign of a congestive heart failure refractory; Left ventricular ejection fraction <35% at myocardial scintigraphy or echocardiography; Pulmonary arterial hypertension with systolic pulmonary artery pressure (PAP) at echography > 40 mmHg Chronic atrial fibrillation requiring oral anticoagulant therapy; Uncontrolled ventricular arrhythmia; Pericardial effusion with hemodynamic compromise assessed by echocardiography.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04896853


Contacts
Layout table for location contacts
Contact: Mathias Svahn, PhD +46 (0)70 2615504 mathias.svahn@nextcellpharma.com

Locations
Layout table for location information
Sweden
Department of Cardiology, Respiratory medicine and Physiology, Örebro University Hospital Recruiting
Örebro, Sweden, 701 85
Contact: Josefin Sundh, MD       Josefin.sundh@regionorebrolan.se   
Sponsors and Collaborators
NextCell Pharma Ab
Karolinska Trial Alliance
Investigators
Layout table for investigator information
Study Chair: Mathias Svahn, PhD NextCell Pharma
Principal Investigator: Josefine Sundh, MD Department of Cardiology, Respiratory medicine and Physiology, Örebro University Hospital
Layout table for additonal information
Responsible Party: NextCell Pharma Ab
ClinicalTrials.gov Identifier: NCT04896853    
Other Study ID Numbers: PRO TRANS 19+
2020-002078-29 ( EudraCT Number )
First Posted: May 21, 2021    Key Record Dates
Last Update Posted: May 21, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Infections
Respiratory Tract Infections
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Pneumonia, Viral
Pneumonia
Virus Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury